Why clinical biomarkers face a slow climb before regulators accept them as surrogate endpoints
Biomarkers can speed drug approvals, but weak validation can haunt sponsors. FDA and EMA are tightening the path from signal to endpoint.
Why Merck and Eisai’s belzutifan–lenvatinib combo could reset treatment sequencing in advanced renal cell carcinoma
Belzutifan plus lenvatinib outperforms cabozantinib in Phase 3 renal cell carcinoma data. Find out what this changes for post-immunotherapy care.
FDA priority review for Leqembi Iqlik could transform Alzheimer’s drug initiation at home
Leqembi Iqlik gets FDA Priority Review for at-home Alzheimer’s treatment initiation. Find out what this could mean for patients, payers, and the care model.